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SCHOOL OF PHARMACY
SCHOOL OF PHARMACY
PHARMACY REGULATORY AFFAIRS

Detailed course offerings (Time Schedule) are available for

To see the detailed Instructor Class Description, click on the underlined instructor name following the course description.

PHRMRA 524 Introduction to Clinical Trials (3) Jonlin
Introduces the major concepts under which clinical trials are designed to run. Focuses on the phases of clinical trials, the role of the Food and Drug Administration, Institutional Review Boards, the Code of Federal Regulations and ethical principles. Addresses study design and statistical concepts. Offered: A.

PHRMRA 525 Implementation and Conduct of Clinical Trials (3) Hammond
Outlines the work of carrying out a clinical trial including the complex work of study initiation, issues of site and data managements, preparation of the final report and study close out, as well as the details that control the study conduct. Offered: W.

PHRMRA 526 Project Management and the Business of Clinical Trials (3) Hammon, Hayashi
Addresses the business dimension of clinical trials. Addresses the principles of project management, planning, analysis, contingency and follow-up within the context of clinical trials that involve a large number of tasks and people responsible for parts of the overall study. Offered: Sp.

PHRMRA 527 International Regulatory Affairs (3) Hammond
Develops an understanding of international differences in the regulation of design, manufacture, and post-marketing surveillance of medical products relative to U.S. Food and Drug Administration requirements. Prerequisite: PHARM 504. Offered: A.

PHRMRA 528 Medical Risk Analysis and Management (3) Loboda
Examines the principles and application of risk management methods in the design, manufacture, and marketing of medical products. Offered: W.
Instructor Course Description: Raisa Loboda

PHRMRA 536 Skills for the Regulatory Affairs Professional (2) Feagin
Covers essential skills in regulatory affairs and includes an overview of local medical products companies. Offered: A.

PHRMRA 545 Data Essentials and Analysis for Regulatory Professionals (3) Magee
Applies statistical methods to medical products design, clinical evaluation, manufacturing, and post-marketing surveillance. Prerequisite: introductory statistics. Offered: Sp.
Instructor Course Description: Sara Magee

PHRMRA 546 Technical Writing for the Medical Products Industries (3) Hazlet
Presents up-to-date information and strategies for effective technical communication within the medical product industries. Addresses the appropriate and correct use of the English language, information design, and the use of computer technology in producing professional documents. Emphasizes communicating technical information to a variety of stakeholders. Offered: A.

PHRMRA 547 Advanced Topics in Medical Products Regulation (2, max. 6) Feagin
Addresses essential topics in medical products regulation. Employs a combination of lecture presentations, case studies, and participants' small group discussion to achieve practical outcomes for regulatory professionals. Offered: W.

PHRMRA 548 Biomedical Regulatory Affairs Practicum ([1-9]-, max. 9) Feagin
Provides a practical experience to ensure that participants are able to shepherd new medical products (drug, device, biologic) through regulatory, clinical, and quality assurance aspects. Includes a project and final report. Offered: AWSpS.

PHRMRA 550 Advanced Technical Writing for Biomedical Regulatory Affairs (2) Teal
Further examines communications with attention to best written practices. Provides an intensive review of common editing and advanced strategies for crafting highly reliable and effective documentation. Prerequisite: PHRMRA 546 or permission of instructor. Credit/no-credit only. Offered: Sp.

PHRMRA 554 Advanced Medical Products Regulation I (2) Feagin
Provides an in-depth exploration of regulatory issues primarily related to non-clinical and clinical aspects of medical product development. Offered: A.

PHRMRA 555 Advanced Medical Products Regulation II (2) Feagin
Provides an in-depth exploration of regulatory issues primarily related to manufacturing, post-marketing concerns, and FDA interactions. Offered: W.

PHRMRA 560 Short Course in Multinational Biomedical Regulatory Affairs (2, max. 30) Hazlet
Presents three medical products registration countries or groupings (for instance, European Union, World Health Organization). Locale based on program impact, unique features, or recent or controversial regulatory issues.

PHRMRA 561 Biotech Project Management - Project Planning and Organization (3-) Schuelein
Focuses on management of the discovery, testing, and manufacturing processes in highly regulated environments, emphasizing the unique project manage challenges of the medical products industry. First in a sequence of two. Offered: ASp.

PHRMRA 562 Biotech Project Management - Project Execution, Monitoring, and Control (-3) Schuelein
Focuses on management of the discovery, testing, and manufacturing processes in highly regulated environments, emphasizing the unique project manage challenges of the medical products industry. Second in a sequence of two. Offered: ASp.

PHRMRA 595 Special Topics in Regulation (1-6, max. 24)
Offered: AWSpS.